Heart and Blood Pressure Study: The Effect of Aortic Impedance on Myocardial Relaxation

Plain-language guide to NCT00204984: not phased non-randomized trial of BNP (Nesiritide), low blood pressure and orthostatic hypotension, 17 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00204984
Phase: not phased
Status: completed
Start: 2005-05
Completion (planned or actual): 2006-12-20
Participants: 17 (actual)
Design: non-randomized, open label (everyone knows who gets what), basic_science
Conditions studied: High Blood Pressure
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around BNP (Nesiritide) for low blood pressure and orthostatic hypotension.

The registry classes the interventions as drug.

More on the Plan

60 subjects, 30 with hypertension and 30 without will attend two visits to the GCRC.

At each visit, pulsatile hemodynamics (by using tonometry-a non-invasive means to obtain arterial pressure tracings) and Doppler tissue imaging relaxation velocity (a measurement of myocardial relaxation obtained by echocardiography) data will be collected before and after administration of vasodilator medication.

Who Took Part

17 actual participants took part.

It was open to people of any sex aged from 65 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Subjects over the age of 65.

The full record lists 1 inclusion and 6 exclusion criteria; among the exclusions: have known or suspected coronary artery disease; have known or suspected left ventricular dysfunction; have a resting systolic blood pressure \< 100 mmhg.

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

Nothing was hidden in this open-label BNP (Nesiritide) study: the low blood pressure and orthostatic hypotension participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2005-05 with completion listed for 2006-12-20.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: heart myocardium relaxation (diastole) (time frame: before and after administration of vasodilator medication).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of BNP (Nesiritide) in 17 people with low blood pressure and orthostatic hypotension.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the BNP (Nesiritide) compound page, Low blood pressure and orthostatic hypotension research.

Our Notes on the Compound

BNP (Nesiritide): B-type natriuretic peptide, a 32-amino-acid heart hormone; nesiritide (Natrecor) is a recombinant form used in acute heart failure.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.